Determining sample size for a binary diagnostic test in the presence of verification bias.

To compare a new binary diagnostic test with the gold standard, sensitivity and specificity are the two common measurements used to evaluate the new test. When not all the patients are verified by the gold standard due to time, budget, or cost considerations, several approaches have been proposed to compute sample size for such studies under the assumption of missing completely at random. However, the majority of them are based on asymptotic approaches that generally do not guarantee the type I and II error rates, and the remaining approaches use exact binomial distributions in sample size calculation but only the verified samples are used. In this article, for a study with verification bias, we propose computing exact sample sizes by using all the samples. The proposed approach is compared with the existing exact approach that compute sample size by using verified samples only, and the results show that the proposed approach requires fewer participants than the competitor.